A Phase 2 Study of ADR-001 in Patients with Severe Pneumonia caused by SARS-CoV-2 infection

A Phase 2 Study of ADR-001 in Patients with Severe Pneumonia caused by SARS-CoV-2 infection (COVID-19)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2053210023

Enrollment

Registered

2021-05-11

Start date

2021-05-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Severe Pneumonia caused by SARS-CoV-2 infection

Interventions

1*10^8 cells of ADR-001 are administered once a week, total four times intravenously.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -SARS-CoV-2 infection is confirmed on antigen test or PCR test -Pulmonary infiltrative shadow is confirmed on chest X-ray test -Just after mechanical ventilation support start (equal to it would be possible to administer an Investigational Product to a subject within 72h from the mechanical ventilation support start) -PaO2/FiO2 <=200mmHg at the time of screening

Exclusion criteria

Exclusion criteria: -Continue Pneumonia before SARS-CoV-2 infection -SOFA score >= 15 -Infection type on DIC diagnosis criteria >= 4 -Deep Venous Thrombosis

Design outcomes

Primary

Measure	Time frame
Ventilator Free Days (Time Frame: Day 28)	—

Secondary

Measure	Time frame
1) Mortality rate(Day 28 and Day 85) 2) Duration of ICU stay(Time Frame: Day 28) 3) Change in Lung opacity score on chest X-ray 4) Change in PaO2/FiO2 5) Change in SpO2/FiO2 6) Change in Oxygen index 7) Change in PEEP 8) Number of days to meet criteria of spontaneous breathing trials by Day29 9) Change in CRP 10) Change in LDH 11) Change in SOFA score 12) Change in Cytokine quantity(IL-6, IL-10, TNF-alpha, KL-6, TARC) 13) Number of days to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category ordinal Scale of Clinical Status by Day 29 14) Number of days Time to Improvement of at Least 3 Categories Relative to Baseline on a 7-Category ordinal Scale of Clinical Status by Day 29 15) Change in 7 category ordinal scale 16) Change in NEWS2 17) Adverse event	—

Measure

Time frame

1) Mortality rate(Day 28 and Day 85) 2) Duration of ICU stay(Time Frame: Day 28) 3) Change in Lung opacity score on chest X-ray 4) Change in PaO2/FiO2 5) Change in SpO2/FiO2 6) Change in Oxygen index 7) Change in PEEP 8) Number of days to meet criteria of spontaneous breathing trials by Day29 9) Change in CRP 10) Change in LDH 11) Change in SOFA score 12) Change in Cytokine quantity(IL-6, IL-10, TNF-alpha, KL-6, TARC) 13) Number of days to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category ordinal Scale of Clinical Status by Day 29 14) Number of days Time to Improvement of at Least 3 Categories Relative to Baseline on a 7-Category ordinal Scale of Clinical Status by Day 29 15) Change in 7 category ordinal scale 16) Change in NEWS2 17) Adverse event

—

Contacts

Public ContactTakayoshi Ono

ROHTO Pharmaceutical Co., Ltd.

adr-001@rohto.co.jp+81-6-6758-6931

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026